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Amiodarone hydrochloride for injection and preparation method thereof

A technology for amiodarone hydrochloride and injection is applied in the field of amiodarone hydrochloride for injection and its preparation, and the field of amiodarone hydrochloride pharmaceutical composition for injection, which can solve the problems of low solubility, long half-life, and problems of amiodarone hydrochloride. Slow absorption and other problems, to achieve the effect of good solubility and good stability

Inactive Publication Date: 2018-03-06
黑龙江迪龙制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] As a powerful antiarrhythmic drug, amiodarone hydrochloride also has certain disadvantages, such as slow absorption, long half-life, and large differences in individual drug use
The low solubility of amiodarone hydrochloride in water makes it difficult to formulate a sufficiently concentrated and stable formulation in a medium with a physiologically acceptable pH

Method used

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  • Amiodarone hydrochloride for injection and preparation method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] Every 20,000 pieces (0.15g / piece) prescription

[0019]

[0020] Preparation Process:

[0021] 1. Pretreatment of raw and auxiliary materials

[0022] Accurately weigh the amiodarone hydrochloride, mannitol, polysorbate 80, and benzyl alcohol of the prescribed amount, put them in a liquid barrel, add water for injection above 80° C. of the total amount of the medicinal liquid, and stir to dissolve. Add 0.2% (W / V) activated carbon for needles to the above solution, and stir and adsorb at 80° C. for 20 minutes. Turn on the pump to decarbonize the liquid medicine through a 5 μm titanium filter stick filter.

[0023] Cool down to below 40°C, turn on the peristaltic pump to send the liquid medicine through a 0.22 μm microporous sterilizing filter into the liquid preparation barrel, and take samples to check the content and pH value.

[0024] 2. Preparation

[0025] Calculate the amount of water for injection based on the test results. Add nearly full amount of water ...

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Abstract

The invention provides amiodarone hydrochloride for injection and a preparation method thereof. The amiodarone hydrochloride for injection is composed of amiodarone hydrochloride and pharmaceutical adjuvants and is characterized in that the pharmaceutical adjuvants are composed of mannitol, polysorbate 80 and benzyl alcohol. The pharmaceutical composition amiodarone hydrochloride for injection isgood in stability and dissolvability, overcomes the technical defects of conventional amiodarone hydrochloride injections and has obviously better effect than other commercially available products.

Description

technical field [0001] The invention provides amiodarone hydrochloride for injection and a preparation method thereof, in particular, provides an amiodarone hydrochloride pharmaceutical composition for injection. It belongs to the field of pharmaceutical preparations. Background technique [0002] Amiodarone hydrochloride (ADHC) is currently one of the most commonly used antiarrhythmic drugs. It is mainly used clinically for supraventricular and ventricular tachyarrhythmias, and is also used for various structural heart diseases and acute coronary syndrome. etc. It can be used as first-line treatment for symptomatic atrial fibrillation with left ventricular dysfunction or chronic heart failure. Occupies 1 / 3 of the prescription market for antiarrhythmic drugs in the United States and Europe. Amiodarone is a multi-channel blocker. It is found in electrophysiological research and clinical application that the drug can achieve the electrophysiological effects of class I, II, I...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/343A61K47/10A61K47/26A61P9/06
CPCA61K9/19A61K9/0019A61K31/343A61K47/10A61K47/26
Inventor 董继胜于芳刘小丹
Owner 黑龙江迪龙制药有限公司
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